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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022379
Receipt No. R000025596
Scientific Title Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Date of disclosure of the study information 2016/07/01
Last modified on 2016/05/20

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Basic information
Public title Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Acronym Usage of rifampicin-bonded gelatin-sealed Dacron graft
Scientific Title Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Scientific Title:Acronym Usage of rifampicin-bonded gelatin-sealed Dacron graft
Region
Japan

Condition
Condition infected aortic aneurysm, vascular graft infection
Classification by specialty
Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 anatomical reconstruction of artery after resection of infected aortic aneurysm or infected vascular graft
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical control of infection (imaging study and/or laboratory study)
Key secondary outcomes patient death

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gelatin-sealed Dacron graft is soaked in rifampicin solution before implantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) patients with infectious aortic aneurysm or vascular graft infection diagnosed by imaging study and/or laboratory study
(2) patients with refractory to medical treatment
Key exclusion criteria (1) patients with allergic for rifampicin
(2) patients who refuse to the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiich Kanda
Organization Kyoto Prefectural University of Medicine
Division name Cardiovascular Surgery
Zip code
Address 465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL 0752515752
Email kei@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiich Kanda
Organization Kyoto Prefectural University of Medicine
Division name Cardiovascular Surgery
Zip code
Address 465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL 0752515752
Homepage URL
Email kei@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Cardiovascular Surgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 20 Day
Last modified on
2016 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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